Programador Estadístico Principal SAS/R (Remoto)

Servalia; Las Palmas de Gran Canaria; Remote; EUR 70,000 - 120,000; Full time

Job summary

Cytel seeks a Senior/Principal Statistical Programmer for a sponsor-dedicated, fully remote role embedded with a global pharmaceutical client. You will oversee SDTM/ADaM work, define.xml and reviewer’s guides, and deliver high-quality programming for regulatory submissions.

You will develop SAS and R programs, supervise CRO deliverables, support study reports, DSURs and regulatory filings, and ensure adherence to FDA/ICH guidelines while leading project activities.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in Biotech/Pharma Clinical Development Biometrics.
• Exceptional SAS programming skills and experience in clinical development.
• Extensive CDISC standards (SDTM, ADaM, Define.xml) and FDA/ICH regulation knowledge.
• Experience supporting regulatory submissions and interactions with FDA or global authorities.
• Ability to work independently and show leadership.
• Excellent written and verbal communication skills.

Responsibilities

• Generate SDTM, ADaM specifications, datasets, reviewer’s guide and define.xml for multiple studies.
• Develop SAS programs to generate datasets, listings, tables and graphs.
• Deliver high-quality SAS and/or R programs tailored to clinical development needs.
• Oversee CRO programming deliverables to meet timelines.
• Support preparation of clinical study reports, regulatory submissions, publications, DSUR and exploratory analyses.
• Follow FDA regulations, GCP and e-submission guidelines.
• Contribute to standards for programming tools, outputs and macros.
• Develop CRFs, edit checks, and data validation plans.
• Provide data transfer specifications for external vendor data.
• Collaborate with internal/external partners to meet project goals.
• Contribute SOPs and Work Instructions related to statistical programming.

Skills

SAS programming

CDISC standards

Regulatory submissions

Independent work

Leadership

Communication

R programming

Statistical programming

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

SAS

R

Unix/Linux

Git

Python

Job description

Cytel seeks a Senior/Principal Statistical Programmer for a sponsor-dedicated, fully remote role embedded with a global pharmaceutical client. You will oversee SDTM/ADaM work, define.xml and reviewer’s guides, and deliver high-quality programming for regulatory submissions.

You will develop SAS and R programs, supervise CRO deliverables, support study reports, DSURs and regulatory filings, and ensure adherence to FDA/ICH guidelines while leading project activities.